Radicle Rest: A Study of Cannabinoids on Sleep and Health Outcomes

Radicle™ Rest: A Randomized, Blinded, Placebo-controlled, Direct-to-consumer Study Assessing the Impact of Plant Derived Cannabinoids on Sleep and Overall Health Outcomes

A randomized, blinded, placebo-controlled, direct-to-consumer study assessing the impact of plant derived cannabinoids on sleep and overall health outcomes

Study Overview

• Status: Completed
• Conditions: Sleep Disorder; Sleep; Sleep Disturbance
• Intervention / Treatment: Dietary supplement: Rest Study Product Usage

Detailed Description

This is a randomized, blinded, placebo-controlled study conducted with up to 300 adult participants per study arm, age 21 and older and residing in the United States.

Eligible participants will (1) endorse a desire for better sleep, (2) indicate a willingness to refrain from taking cannabinoids during the study period, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study.

Participants with known liver disease, heavy drinkers, and those who are pregnant, trying to become pregnant, or breastfeeding will be excluded. Those taking medications that warn against grapefruit consumption will be excluded.

Self-reported data are collected electronically from eligible participants over 5 weeks. Participant reports of health indicators will be collected during baseline, throughout the active period of study product use, and in a final survey. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.

• Study Type: Interventional
• Enrollment (Actual): 2679
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Del Mar, California, United States, 92014
      • Radicle Science, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 105 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 21 years of age and older
• Resides in the United States
• Endorses a desire for better sleep
• Selects sleep as a primary reason for taking a cannabinoid product
• Expresses a willingness to refrain from taking any non-study cannabinoid product (i.e. CBD, CBG, CBC, CBN, THC) for the duration of participant engagement (5 weeks)
• Expresses an interest in taking a study product and not knowing the product identity until the end of the study

Exclusion Criteria:

• Pregnant, trying to become pregnant, or breastfeeding
• Reports a diagnosis of liver disease
• Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
• Unable to read and understand English
• Lack of reliable daily access to the internet
• Reports taking any medication that warns against grapefruit consumption

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

13

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Control 1; Rest Product Form 1 - control	Dietary supplement: Rest Study Product Usage; Participants will use their Radicle Rest study product as directed for a period of 4 weeks.
Placebo Comparator: Placebo Control 2; Rest Product Form 2 - control	Dietary supplement: Rest Study Product Usage; Participants will use their Radicle Rest study product as directed for a period of 4 weeks.
Placebo Comparator: Placebo Control 3; Rest Product Form 3 - control	Dietary supplement: Rest Study Product Usage; Participants will use their Radicle Rest study product as directed for a period of 4 weeks.
Experimental: Active Product 1.1; Rest Product Form 1 - active product 1	Dietary supplement: Rest Study Product Usage; Participants will use their Radicle Rest study product as directed for a period of 4 weeks.
Experimental: Active Product 1.2; Rest Product Form 1 - active product 2	Dietary supplement: Rest Study Product Usage; Participants will use their Radicle Rest study product as directed for a period of 4 weeks.
Experimental: Active Product 2.1; Rest Product Form 2 - active product 1	Dietary supplement: Rest Study Product Usage; Participants will use their Radicle Rest study product as directed for a period of 4 weeks.
Experimental: Active Product 2.2; Rest Product Form 2 - active product 2	Dietary supplement: Rest Study Product Usage; Participants will use their Radicle Rest study product as directed for a period of 4 weeks.
Experimental: Active Product 3.1; Rest Product Form 3 - active product 1	Dietary supplement: Rest Study Product Usage; Participants will use their Radicle Rest study product as directed for a period of 4 weeks.
Experimental: Active Product 3.2; Rest Product Form 3 - active product 2	Dietary supplement: Rest Study Product Usage; Participants will use their Radicle Rest study product as directed for a period of 4 weeks.
Experimental: Active Product 1.3; Rest Product Form 1 - active product 3	Dietary supplement: Rest Study Product Usage; Participants will use their Radicle Rest study product as directed for a period of 4 weeks.
Experimental: Active Product 1.4; Rest Product Form 1 - active product 4	Dietary supplement: Rest Study Product Usage; Participants will use their Radicle Rest study product as directed for a period of 4 weeks.
Placebo Comparator: Placebo Control 4; Rest Product Form 4 - control	Dietary supplement: Rest Study Product Usage; Participants will use their Radicle Rest study product as directed for a period of 4 weeks.
Experimental: Active Product 4; Rest Product Form 4 - active product 1	Dietary supplement: Rest Study Product Usage; Participants will use their Radicle Rest study product as directed for a period of 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in sleep disturbance	Mean difference in sleep disturbance score as assessed by Patient Reported Outcome Measurement System (PROMIS) Sleep Disturbance Short Form 8A (scale 8-40; where higher scores correspond to greater sleep disturbance)	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in overall well-being	Mean difference in well-being score as assessed by World Health Organization 5 (WHO 5; scale 0-25; with 0 representing the worst imaginable well-being and 25 representing the best imaginable well-being)	4 weeks
Change in overall quality of life (QOL)	Mean difference in QOL score as assessed by Kemp QOL (scale 1-7; with 1 representing very poor QOL and 7 representing excellent QOL)	4 weeks
Change in anxiety	Mean difference in anxiety score as assessed by PROMIS Anxiety 4A (scale 4-20; with higher scores corresponding to more severe anxiety)	4 weeks
Change in pain	Mean difference in pain score as assessed by the Pain on average, Enjoyment of life, and General activity score (PEG; scale 0-10; with 0 representing no pain and 10 representing the worst pain imaginable that completely interferes with enjoyment of life and general activities)	4 weeks
Change in stress	Mean difference in stress score as assessed by PROMIS Stress 4A (scale 4-20; where higher scores correspond to more severe stress)	4 weeks
Change in fatigue	Mean difference in fatigue score as assessed by PROMIS Fatigue 4A (scale 4-20; where higher scores correspond to more severe fatigue)	4 weeks
Minimal clinically important difference (MCID) in sleep disturbance	Likelihood of achieving a MCID in sleep disturbance, as measured by PROMIS Sleep Disturbance Short Form 8A (scale 8-40; where higher scores correspond to greater sleep disturbance)	4 weeks

Collaborators and Investigators

• Sponsor: Radicle Science
• Investigators: Principal Investigator: Emily K. Pauli, PharmD, Radicle Science, Inc

Publications and helpful links

Helpful Links

• Radicle Science, Inc

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2022
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): April 11, 2023

Study Registration Dates

• First Submitted: August 10, 2022
• First Submitted That Met QC Criteria: August 22, 2022
• First Posted (Actual): August 23, 2022

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Sleep Wake Disorders; Dyssomnias; Parasomnias
• Other Study ID Numbers: RADX-22D03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will not be shared with researchers outside of Radicle Collaborators on this study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No